Assistant Manager
Medtronic
مجموع سنوات الخبرة :13 years, 4 أشهر
• Manage, plan and execute the preparation, review and submission of dossiers for product registrations, import licenses and other approvals from regulatory agencies (registrations and renewals) thereby supporting the business units and supply chain management in compliance with regulatory requirements in the Indian Sub-Continent (India, Sri Lanka, Bangladesh, Nepal)
• Coordination with global regulatory teams, local BU & other functions, for regulatory strategies and all documentation support required for regulatory submissions in Indian Sub-Continent.
• Submit and track registration/re-registration applications with the authorities.
• Liaise with product divisions and obtain relevant details for filing changes to the approved products/licenses.
• Assess the Change controls from the product divisions through post approval change management and continuously ensure regulatory compliance (reporting of adverse events/field actions, etc.).
• Understanding & interpretation of law & the local regulatory requirement and implementing same in submission with compliance.
• Close monitoring of any changes in local & global regulations and communicating same within the department and respecting & following all SOP / system implemented within the department and organization.
• Ensure business continuity through regulatory filings, obtaining regulatory approvals and continuously ensuring regulatory compliance. Also ensure continuous implementation of the Quality Management System in India.
• Supporting the Marketing Teams on Tender related issues
Categories and Brands: Medical Device (Durex & Kohinoor) Cosmetics (Dettol Range), Healthcare OTC (Strepsils, Gaviscon Mucinex, Cold & Dettol)
Regulatory strategies for Medical Device, Drug, Cosmetic & Pesticide products launches and preparing regulatory submissions to Regulatory Agencies,
• Assist in the development and maintenance regulatory trends and competitor regulatory watch system; identify the key regulatory and competitor trends likely to impact our global business and formulate potential responses.
• Assist manager in training of personnel on regulatory requirements and potential issues impacting the Products.
• Compilation, review and submissions of dossiers/ query handling for New Drug Applications,
• Subsequent- New Drug Application, Product Registration & Renewals,
• Ensure complete regulatory compliance of all products across categories
• Support to the Indian and Export Business with required documents e.g., Product Approvals/ License, Free Sale Certificate, Forms Related to DCG(I)/ SFDA (
• Preparation & post approval maintenance of Product Compliance Summary (PCS’s).
• Proactively identify and resolve opportunities/issues that could affect the regulatory compliance of products
• Develop out of the box regulatory strategies to ensure smooth new category launch in India.
• Product claim, Artwork and communication support.
• Support to the Indian and Export Business with required documents e.g., Product Approvals/ License, Forms Related to DCG(I)/ SFDA (Test License, , Export NOC, Dual use NOC & Form 29 NOC etc.),
• Approval of Artworks with respect to country specific Guidelines (Global Project’s Line Extension - NPD & EPD).
• Keep updating the Factory & Global Regulatory Team about the regulations w.r.t. DCG(I) Notification/Regulations
• Development of Artworks and labels are per requirement of Drugs and Cosmetic Act 1940 and Rules 1945 in coordination with Quality Team
• Liaison with External Stakeholder - Strongly Interaction with Regulatory FDA
Officers.
Preparation of Dossiers for Medical Devices.
Submissions of application at DCGI office
Follow up for the Files submitted at DCGI office.
Tracking the files and preparing Monthly reports
Documentation Archival Management
Timely response to DCGI for the technical queries / deficiency letters
Liaison with Internal stakeholders - Interaction with Global and Regional Fenwal Employees.
Liaison with External Stakeholder - Interaction with Regulatory Consultant and FDA officers.
Technical Support to the APAC Regional Manager